Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090962
Company: PLIVA HRVATSKA DOO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/02/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090962s000ltr.pdf

ADAPALENE

GEL;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Prescription No AB 091314 GLENMARK GENERICS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Prescription No AB 090962 PLIVA HRVATSKA DOO

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